ID
44921
Beschrijving
Study ID: 105-040 Clinical Study ID: 105-040 Study Title: A Multicenter, Double-Blind, Placebo-Controlled, Parallel-Design Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients Patient Level Data: Study Listed on ClinicalStudyDataRequest.com Sponsor: GlaxoSmithKline Collaborators: N/A Phase: Phase 3 Study Recruitment Status: Completed Generic Name: lamotrigine Trade Name: lamictal Study Indication: Epilepsy, Partial
Trefwoorden
Versies (4)
- 27-09-18 27-09-18 -
- 27-09-18 27-09-18 -
- 08-10-18 08-10-18 -
- 20-04-22 20-04-22 - Martin Dugas
Houder van rechten
GlaxoSmithKline
Geüploaded op
20 april 2022
DOI
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Licentie
Creative Commons BY-NC 4.0
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Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients 105-040
Study Continuitation Record, Vital Signs/Weight, Neurological Examination, Laboratory Comments, Clinical Laboratory Examination and Plasma Samples- Treatment Phase Study Week 22
- StudyEvent: Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients 105-040
Beschrijving
Study Subject Participation Status | Assessment Date
Alias
- UMLS CUI-1
- C2348568
- UMLS CUI-2
- C2985720
Beschrijving
Study Subject Participation Status | Clinical Trial Eligibility Criteria
Alias
- UMLS CUI-1
- C2348568
- UMLS CUI-2
- C1516637
Beschrijving
Menarche; Visit; Last; Since
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0025274
- UMLS CUI [1,2]
- C0545082
- UMLS CUI [1,3]
- C1517741
- UMLS CUI [1,4]
- C1711239
Beschrijving
Menarche | Pregnancy | Serum pregnancy test negative | Breast Feeding
Datatype
boolean
Alias
- UMLS CUI [1]
- C0025274
- UMLS CUI [2]
- C0032961
- UMLS CUI [3]
- C0430061
- UMLS CUI [4]
- C0006147
Beschrijving
Contraceptive methods; Pharmaceutical Preparations | Contraceptive methods; Devices | Contraceptive methods; Abstinence
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0700589
- UMLS CUI [1,2]
- C0013227
- UMLS CUI [2,1]
- C0700589
- UMLS CUI [2,2]
- C0699733
- UMLS CUI [3,1]
- C0700589
- UMLS CUI [3,2]
- C3843422
Beschrijving
Statement; Signature; Pregnancy; avoidance
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1710187
- UMLS CUI [1,2]
- C1519316
- UMLS CUI [1,3]
- C0032961
- UMLS CUI [1,4]
- C0870186
Beschrijving
Physical Examination Date
Alias
- UMLS CUI-1
- C2826643
Beschrijving
Vital signs | Body Weight
Alias
- UMLS CUI-1
- C0518766
- UMLS CUI-3
- C0005910
Beschrijving
Blood Pressure
Datatype
text
Maateenheden
- mmHg
Alias
- UMLS CUI [1]
- C0005823
Beschrijving
Pulse Rate
Datatype
integer
Maateenheden
- bpm
Alias
- UMLS CUI [1]
- C0232117
Beschrijving
Body Weight
Datatype
float
Maateenheden
- kg
Alias
- UMLS CUI [1]
- C0005910
Beschrijving
Neurologic Examination; Date in time |On examination - neurological findings
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C0011008
- UMLS CUI-3
- C0437208
Beschrijving
Neurologic Examination; Date in time
Datatype
date
Alias
- UMLS CUI [1,1]
- C0027853
- UMLS CUI [1,2]
- C0011008
Beschrijving
Neurological examination normal | On examination - neurological findings
Datatype
integer
Alias
- UMLS CUI [1]
- C1112287
- UMLS CUI [2]
- C0437208
Beschrijving
Neurologic Examination | Abnormalities | Mental state
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0278060
Beschrijving
Abnormality; Mental state
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0278060
Beschrijving
Abnormality; Mental state; Other; Specification
Datatype
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0278060
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Beschrijving
Abnormality; Mental state
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0278060
Beschrijving
Abnormality; Severities | Mental state (observable entity)
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0439793
- UMLS CUI [2]
- C0278060
Beschrijving
Neurologic Examination; Abnormalities | Speech and language finding
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0564649
Beschrijving
Speech Disorders | Languages; Abnormality
Datatype
integer
Alias
- UMLS CUI [1]
- C0037822
- UMLS CUI [2,1]
- C0023008
- UMLS CUI [2,2]
- C1704258
Beschrijving
Abnormality; Speech | Abnormality; Languages
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0037817
- UMLS CUI [2,1]
- C1704258
- UMLS CUI [2,2]
- C0023008
Beschrijving
Abnormality; Severities; Speech | Abnormality; SeveritiesL; anguages
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0439793
- UMLS CUI [1,3]
- C0037817
- UMLS CUI [2,1]
- C1704258
- UMLS CUI [2,2]
- C0439793
- UMLS CUI [2,3]
- C0023008
Beschrijving
Neurologic Examination; Abnormalities | Cranial Nerves
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-4
- C0010268
Beschrijving
Cranial Nerves; Abnormality
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0010268
- UMLS CUI [1,2]
- C1704258
Beschrijving
Abnormality; Cranial Nerves
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0010268
Beschrijving
Abnormality; Severities; Cranial Nerves
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0439793
- UMLS CUI [1,3]
- C0010268
Beschrijving
Abnormality; Cranial Nerves; Other; Specification
Datatype
text
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0010268
- UMLS CUI [1,3]
- C0205394
- UMLS CUI [1,4]
- C2348235
Beschrijving
Neurologic Examination; Abnormalities | Gait
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0016928
Beschrijving
Gait; Abnormality
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0016928
- UMLS CUI [1,2]
- C1704258
Beschrijving
Abnormality; Gait
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0016928
Beschrijving
Abnormality; Severities; Gait
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0439793
- UMLS CUI [1,3]
- C0016928
Beschrijving
Neurologic Examination | Abnormality | Physiologic Coordination
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0242414
Beschrijving
Physiologic Coordination; Abnormality
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0242414
- UMLS CUI [1,2]
- C1704258
Beschrijving
Abnormality; Physiologic Coordination
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0242414
Beschrijving
Abnormality; Severities; Physiologic Coordination
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0439793
- UMLS CUI [1,3]
- C0242414
Beschrijving
Neurologic Examination | Abnormality | Esthesia
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0036658
Beschrijving
Esthesia; Abnormality
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0036658
- UMLS CUI [1,2]
- C1704258
Beschrijving
Abnormality; Esthesia
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0036658
Beschrijving
Abnormality; Severities; Esthesia
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0439793
- UMLS CUI [1,3]
- C0036658
Beschrijving
Neurologic Examination | Abnormality | Muscle strength
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0517349
Beschrijving
Muscle Strength; Abnormality
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0517349
- UMLS CUI [1,2]
- C1704258
Beschrijving
Abnormality; Muscle Strength
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0517349
Beschrijving
Abnormality; Severities; Muscle Strength
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0439793
- UMLS CUI [1,3]
- C0517349
Beschrijving
Neurologic Examination | Abnormality | Muscle Tonus
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0026841
Beschrijving
Muscle Tonus; Abnormality
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0026841
- UMLS CUI [1,2]
- C1704258
Beschrijving
Abnormality; Muscle Tonus
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0026841
Beschrijving
Abnormality; Severities; Muscle Tonus
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0439793
- UMLS CUI [1,3]
- C0026841
Beschrijving
Neurologic Examination | Abnormality | Reflex action
Alias
- UMLS CUI-1
- C0027853
- UMLS CUI-2
- C1704258
- UMLS CUI-3
- C0034929
Beschrijving
Reflex action; Abnormality
Datatype
integer
Alias
- UMLS CUI [1,1]
- C0034929
- UMLS CUI [1,2]
- C1704258
Beschrijving
Abnormality; Reflex action
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0034929
Beschrijving
Abnormality; Type - attribute; Reflex action
Datatype
integer
Alias
- UMLS CUI [1,1]
- C1704258
- UMLS CUI [1,2]
- C0332307
- UMLS CUI [1,3]
- C0034929
Beschrijving
Laboratory; Specimen collection date
Alias
- UMLS CUI-1
- C0022877
- UMLS CUI-2
- C1302413
Beschrijving
Laboratory test finding
Alias
- UMLS CUI-1
- C0587081
Beschrijving
Laboratory Results; Clinical Significance; Unexpected
Alias
- UMLS CUI-1
- C1254595
- UMLS CUI-2
- C2826293
- UMLS CUI-3
- C4055646
Beschrijving
Laboratory; Parameter Value
Datatype
text
Alias
- UMLS CUI [1,1]
- C0022877
- UMLS CUI [1,2]
- C0549193
Beschrijving
Comment | Laboratory; Parameter Value
Datatype
text
Alias
- UMLS CUI [1]
- C0947611
- UMLS CUI [2,1]
- C0022877
- UMLS CUI [2,2]
- C0549193
Beschrijving
Laboratory examination; Clinical | Hematology (discipline)
Alias
- UMLS CUI-1
- C0260877
- UMLS CUI-2
- C0205210
- UMLS CUI-3
- C0018943
Beschrijving
Hemoglobin
Datatype
float
Maateenheden
- g/dl
Alias
- UMLS CUI [1]
- C0019046
Beschrijving
Erythrocyte Mean Corpuscular Volume Measurement
Datatype
float
Alias
- UMLS CUI [1]
- C1948043
Beschrijving
Platelet Count measurement
Datatype
float
Alias
- UMLS CUI [1]
- C0032181
Beschrijving
White Blood Cell Count procedure
Datatype
float
Alias
- UMLS CUI [1]
- C0023508
Beschrijving
Differential white blood cell count procedure
Datatype
text
Alias
- UMLS CUI [1]
- C0162401
Beschrijving
Laboratory examination; Clinical | Chemistry, Clinical
Alias
- UMLS CUI-1
- C0260877
- UMLS CUI-2
- C0205210
- UMLS CUI-3
- C0008000
Beschrijving
Sodium measurement
Datatype
float
Maateenheden
- mmol/l
Alias
- UMLS CUI [1]
- C0337443
Beschrijving
Potassium measurement
Datatype
float
Maateenheden
- mmol/l
Alias
- UMLS CUI [1]
- C0202194
Beschrijving
Bicarbonate measurement
Datatype
float
Alias
- UMLS CUI [1]
- C0202059
Beschrijving
Creatinine measurement, serum (procedure)
Datatype
float
Maateenheden
- mg/dl
Alias
- UMLS CUI [1]
- C0201976
Beschrijving
Bilirubin, total measurement
Datatype
float
Alias
- UMLS CUI [1]
- C0201913
Beschrijving
Alkaline phosphatase measurement
Datatype
float
Alias
- UMLS CUI [1]
- C0201850
Beschrijving
Aspartate aminotransferase measurement
Datatype
float
Alias
- UMLS CUI [1]
- C0201899
Beschrijving
Alanine aminotransferase measurement
Datatype
float
Alias
- UMLS CUI [1]
- C0201836
Beschrijving
Albumin measurement
Datatype
float
Alias
- UMLS CUI [1]
- C0201838
Beschrijving
Plasma Glucose Measurement
Datatype
float
Alias
- UMLS CUI [1]
- C0202042
Beschrijving
Urinalysis; Urine dipstick test
Alias
- UMLS CUI-1
- C0042014
- UMLS CUI-2
- C0430370
Beschrijving
Serum pregnancy test (B-HCG)
Alias
- UMLS CUI-1
- C0430060
Beschrijving
plasma concentration; Antiepileptic Agents
Alias
- UMLS CUI-1
- C0683150
- UMLS CUI-2
- C0003299
Beschrijving
Plasma specimen
Alias
- UMLS CUI-1
- C0444263
Beschrijving
Plasma specimen | Antiepileptic Agents; Trough
Datatype
text
Alias
- UMLS CUI [1,1]
- C0003299
- UMLS CUI [1,2]
- C0444506
Beschrijving
Experimental drug; Trough | Date in time; Time; Specimen Collection
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0444506
- UMLS CUI [2,1]
- C0011008
- UMLS CUI [2,2]
- C0040223
- UMLS CUI [2,3]
- C0200345
Beschrijving
Experimental drug; Date last dose | Experimental drug; Time last dose
Datatype
datetime
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C1762893
- UMLS CUI [2,1]
- C0304229
- UMLS CUI [2,2]
- C0946444
Beschrijving
Experimental drug; Dosage
Datatype
float
Maateenheden
- mg
Alias
- UMLS CUI [1,1]
- C0304229
- UMLS CUI [1,2]
- C0178602
Similar models
Study Continuitation Record, Vital Signs/Weight, Neurological Examination, Laboratory Comments, Clinical Laboratory Examination and Plasma Samples- Treatment Phase Study Week 22
- StudyEvent: Evaluation of LAMICTAL for Add-on Treatment of Partial Seizures in Pediatric Patients 105-040
C0237753 (UMLS CUI [1,2])
C2985720 (UMLS CUI-2)
C1516637 (UMLS CUI-2)
C0545082 (UMLS CUI [1,2])
C1517741 (UMLS CUI [1,3])
C1711239 (UMLS CUI [1,4])
C0032961 (UMLS CUI [2])
C0430061 (UMLS CUI [3])
C0006147 (UMLS CUI [4])
C0013227 (UMLS CUI [1,2])
C0700589 (UMLS CUI [2,1])
C0699733 (UMLS CUI [2,2])
C0700589 (UMLS CUI [3,1])
C3843422 (UMLS CUI [3,2])
C1519316 (UMLS CUI [1,2])
C0032961 (UMLS CUI [1,3])
C0870186 (UMLS CUI [1,4])
C0011008 (UMLS CUI-2)
C0437208 (UMLS CUI-3)
C0011008 (UMLS CUI [1,2])
C0437208 (UMLS CUI [2])
C1704258 (UMLS CUI-2)
C0278060 (UMLS CUI-3)
C0278060 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C0439793 (UMLS CUI [1,2])
C0278060 (UMLS CUI [2])
C1704258 (UMLS CUI-2)
C0564649 (UMLS CUI-3)
C0023008 (UMLS CUI [2,1])
C1704258 (UMLS CUI [2,2])
C0037817 (UMLS CUI [1,2])
C1704258 (UMLS CUI [2,1])
C0023008 (UMLS CUI [2,2])
C0439793 (UMLS CUI [1,2])
C0037817 (UMLS CUI [1,3])
C1704258 (UMLS CUI [2,1])
C0439793 (UMLS CUI [2,2])
C0023008 (UMLS CUI [2,3])
C1704258 (UMLS CUI-2)
C0010268 (UMLS CUI-4)
C0439793 (UMLS CUI [1,2])
C0010268 (UMLS CUI [1,3])
C0010268 (UMLS CUI [1,2])
C0205394 (UMLS CUI [1,3])
C2348235 (UMLS CUI [1,4])
C1704258 (UMLS CUI-2)
C0016928 (UMLS CUI-3)
C0439793 (UMLS CUI [1,2])
C0016928 (UMLS CUI [1,3])
C1704258 (UMLS CUI-2)
C0242414 (UMLS CUI-3)
C1704258 (UMLS CUI [1,2])
C0242414 (UMLS CUI [1,2])
C0439793 (UMLS CUI [1,2])
C0242414 (UMLS CUI [1,3])
C1704258 (UMLS CUI-2)
C0036658 (UMLS CUI-3)
C0439793 (UMLS CUI [1,2])
C0036658 (UMLS CUI [1,3])
C1704258 (UMLS CUI-2)
C0517349 (UMLS CUI-3)
C0439793 (UMLS CUI [1,2])
C0517349 (UMLS CUI [1,3])
C1704258 (UMLS CUI-2)
C0026841 (UMLS CUI-3)
C0439793 (UMLS CUI [1,2])
C0026841 (UMLS CUI [1,3])
C1704258 (UMLS CUI-2)
C0034929 (UMLS CUI-3)
C0332307 (UMLS CUI [1,2])
C0034929 (UMLS CUI [1,3])
C2826293 (UMLS CUI [1,2])
C4055646 (UMLS CUI [1,3])
C2826293 (UMLS CUI-2)
C4055646 (UMLS CUI-3)
C0549193 (UMLS CUI [1,2])
C0022877 (UMLS CUI [2,1])
C0549193 (UMLS CUI [2,2])
C0205210 (UMLS CUI-2)
C0018943 (UMLS CUI-3)
C0205210 (UMLS CUI-2)
C0008000 (UMLS CUI-3)
C0003299 (UMLS CUI [1,2])
C0444506 (UMLS CUI [1,3])
C0444506 (UMLS CUI [1,2])
C0444506 (UMLS CUI [1,2])
C0011008 (UMLS CUI [2,1])
C0040223 (UMLS CUI [2,2])
C0200345 (UMLS CUI [2,3])
C1762893 (UMLS CUI [1,2])
C0304229 (UMLS CUI [2,1])
C0946444 (UMLS CUI [2,2])
C0178602 (UMLS CUI [1,2])